Advanced biomedical innovations are
leading to safer and more effective therapies for patients. At the same time, global
strategies are necessary to ensure the quality of these cutting-edge medical products.
With change in the air, where can you
hear what company executives are doing
to supply quality, innovative products
for the global marketplace? And what do
regulators and industry thought leaders
think of the future of pharma?
This year’s
PDA/FDA Joint Regulatory Conference
offers answers to these
questions within the theme, “Ensuring
Product Quality in an Era of Innovative
Therapies.” Some of the plenary sessions
have been transformed into panel discussions. Here, thought leaders from the US
FDA and industry are poised to discuss
future trends for the industry and the
importance of innovative therapies as the industry moves forward. Other plenary
sessions will feature company executives
sharing their expertise about the challenges executive management faces and how
their decisions impact quality. Concurrent
sessions will fall under the following three
tracks: “Product Quality,” “Lifecycle,” and
“Innovation.” “Product Quality” includes
sessions focusing on data integrity and
quality metrics. “Lifecycle” sessions will
look at quality systems, change and risk
management, lifecycle management, and
global harmonization trends. And the “Innovation” track will tackle such subjects
as the importance of expedited pathways
and advanced therapies, and will include a
discussion of the current regulatory findings taken directly from the most current
Form 483 citations.
Last, but not least, a variety of breakfast
sessions will entice even night owls to get
up early. These sessions will cover SOPs,
investigations, good documentation practices, practical guidance for conducting
smoke studies and media fills, API quality
requirements for sterile drug manufacturing, and laboratory controls.
As you can see, there will be a topic of interest for everyone, from recent graduates to
seasoned experts. So be sure to mark your
calendar and join us this September!
Learn more about the 2017 PDA/FDA Joint Regulatory Conference and related PDA Education courses!
